scispace - formally typeset
Search or ask a question
Topic

Randomized controlled trial

About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.


Papers
More filters
Journal ArticleDOI
03 Mar 2004-JAMA
TL;DR: Evidence of the intervention's effectiveness in reducing suicidal ideation, regardless of depression severity, reinforces its role as a prevention strategy to reduce risk factors for suicide in late life.
Abstract: ContextSuicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation.ObjectiveTo determine the effect of a primary care intervention on suicidal ideation and depression in older patients.Design and SettingRandomized controlled trial known as PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 20 primary care practices in New York City, Philadelphia, and Pittsburgh regions, May 1999 through August 2001.ParticipantsTwo-stage, age-stratified (60-74, ≥75 years) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of screened negative patients. This analysis included patients with a depression diagnosis (N = 598).InterventionTreatment guidelines tailored for the elderly with care management compared with usual care.Main Outcome MeasuresAssessment of suicidal ideation and depression severity at baseline, 4 months, 8 months, and 12 months.ResultsRates of suicidal ideation declined faster (P = .01) in intervention patients compared with usual care patients; at 4 months, in the intervention group, raw rates of suicidal ideation declined 12.9% points (29.4% to 16.5%) compared with 3.0% points (20.1% to 17.1% in usual care [P = .01]). Among patients reporting suicidal ideation, resolution of ideation was faster among intervention patients (P = .03); differences peaked at 8 months (70.7% vs 43.9% resolution; P = .005). Intervention patients had a more favorable course of depression in both degree and speed of symptom reduction; group difference peaked at 4 months. The effects on depression were not significant among patients with minor depression unless suicidal ideation was present.ConclusionsEvidence of the intervention's effectiveness in community-based primary care with a heterogeneous sample of depressed patients introduces new challenges related to its sustainability and dissemination. The intervention's effectiveness in reducing suicidal ideation, regardless of depression severity, reinforces its role as a prevention strategy to reduce risk factors for suicide in late life.

944 citations

Journal ArticleDOI
18 Dec 2002-JAMA
TL;DR: In this article, the authors evaluated the efficacy of standardized health-related quality-of-life (HRQL) assessments in facilitating patient-physician communication and increasing physicians' awareness of their patients' HRQLrelated problems.
Abstract: ContextThere has been increasing interest in the use of health-related quality-of-life (HRQL) assessments in daily clinical practice, yet few empirical studies have been conducted to evaluate the usefulness of such assessments.ObjectiveTo evaluate the efficacy of standardized HRQL assessments in facilitating patient-physician communication and increasing physicians' awareness of their patients' HRQL-related problems.DesignProspective, randomized crossover trial.SettingOutpatient clinic of a cancer hospital in the Netherlands.ParticipantsTen physicians and 214 patients (76% women; mean age, 57 years) undergoing palliative chemotherapy who were invited to participate between June 1996 and June 1998.InterventionAt 3 successive outpatient visits, patients completed an HRQL questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30). The responses were computer scored and transformed into a graphic summary. Physicians and patients received a copy of the summary before the consultation.Main Outcome MeasuresAudiotapes of the consultations were content analyzed to evaluate patient-physician communication. Physicians' awareness of their patients' health problems was assessed by comparing physicians' and patients' ratings on the Dartmouth Primary Care Cooperative Information Functional Health Assessment (COOP) and the World Organisation Project of National Colleges and Academics (WONCA) charts.ResultsThe HRQL-related issues were discussed significantly more frequently in the intervention than in the control group (mean [SD] communication composite scores: 4.5 [2.3] vs 3.7 [1.9], respectively (P = .01). Physicians in the intervention group identified a greater percentage of patients with moderate-to-severe health problems in several HRQL domains than did those in the control group. All physicians and 87% of the patients believed that the intervention facilitated communication and expressed interest in its continued use.ConclusionIncorporating standardized HRQL assessments in daily clinical oncology practice facilitates the discussion of HRQL issues and can heighten physicians' awareness of their patients' HRQL.

944 citations

Journal ArticleDOI
TL;DR: Ketamine demonstrated rapid antidepressant effects in an optimized study design, further supporting NMDA receptor modulation as a novel mechanism for accelerated improvement in severe and chronic forms of depression.
Abstract: Intravenous ketamine demonstrated rapid antidepressant effects in an optimized study design, improving depression severity in 64% of treatment-resistant patients 24 hours after a single dose. The double-blind trial provides evidence for the role of the N-methyl-d-aspartate glutamate receptor in depression, a receptor not currently activated by existing antidepressant drugs.

943 citations

Journal ArticleDOI
TL;DR: The results from this trial suggest that intensive lifestyle interventions are effective in helping patients to achieve management of cardiovascular risk factors and reducing the need to initiate medication usage to manage these conditions, though the benefits in terms of the prevention of CVD morbidity and mortality beyond those achieved through aggressive medical management of hypertension and dyslipidemia is not clear.
Abstract: Look AHEAD (Action for Health in Diabetes) was a randomized controlled trial that examined the impact of long-term participation in an intensive weight loss intervention on cardiovascular disease (CVD) morbidity and mortality in people with type 2 diabetes (T2D). The results from this trial suggest that intensive lifestyle interventions are effective in helping patients to achieve management of cardiovascular risk factors and reducing the need to initiate medication usage to manage these conditions, though the benefits in terms of the prevention of CVD morbidity and mortality beyond those achieved through aggressive medical management of hypertension and dyslipidemia is not clear. Additional benefits of participation in an intensive lifestyle intervention such as lowered chronic kidney disease risk, blood pressure, medication usage, improved sleep apnea, and partial remission of diabetes are discussed.

943 citations

Journal ArticleDOI
25 Oct 2012-PLOS ONE
TL;DR: Based on the current clinical trials, MSC therapy appears safe, however, further larger scale controlled clinical trials with rigorous reporting of adverse events are required to further define the safety profile of MSCs.
Abstract: Background Mesenchymal stromal cells (MSCs, “adult stem cells”) have been widely used experimentally in a variety of clinical contexts. There is interest in using these cells in critical illness, however, the safety profile of these cells is not well known. We thus conducted a systematic review of clinical trials that examined the use MSCs to evaluate their safety. Methods and Findings MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (to June 2011), were searched. Prospective clinical trials that used intravascular delivery of MSCs (intravenously or intra-arterially) in adult populations or mixed adult and pediatric populations were identified. Studies using differentiated MSCs or additional cell types were excluded. The primary outcome adverse events were grouped according to immediate events (acute infusional toxicity, fever), organ system complications, infection, and longer term adverse events (death, malignancy). 2347 citations were reviewed and 36 studies met inclusion criteria. A total of 1012 participants with clinical conditions of ischemic stroke, Crohn's disease, cardiomyopathy, myocardial infarction, graft versus host disease, and healthy volunteers were included. Eight studies were randomized control trials (RCTs) and enrolled 321 participants. Meta-analysis of the RCTs did not detect an association between acute infusional toxicity, organ system complications, infection, death or malignancy. There was a significant association between MSCs and transient fever. Conclusions Based on the current clinical trials, MSC therapy appears safe. However, further larger scale controlled clinical trials with rigorous reporting of adverse events are required to further define the safety profile of MSCs.

940 citations


Network Information
Related Topics (5)
Odds ratio
68.7K papers, 3M citations
94% related
Risk factor
91.9K papers, 5.7M citations
93% related
Anxiety
141.1K papers, 4.7M citations
85% related
Public health
158.3K papers, 3.9M citations
84% related
Survival rate
73.3K papers, 3.5M citations
84% related
Performance
Metrics
No. of papers in the topic in previous years
YearPapers
20241
202317,032
202234,327
202112,220
202010,774
20199,017